Kornimate/medical-research-clean huggingface dataset:
assessment study of three different fasting plasma glucose targets in chinese patients with type 2 diabetes mellitus (beyond iii/fpg goal)

Conditions: Type 2 Diabetes Mellitus

Summary: primary objective: to identify a best fasting plasma glucose (fpg) target for chinese type 2 diabetes patients using insulin glargine which can provide the highest control rate of glycated hemoglobin (hba1c) \< 7%. secondary objectives: the control rate of hba1c ≤6.5% achievement. the control rate of hba1c \<7.0% in patients achieving their fpg target. the percentage of hba1c \<7% without hypoglycemia. the percentage of patients achieving the fpg target without hypoglycemia. the percentage of patients achieving the fpg target and post prandial glucose (ppg) target (2-hour post breakfast \<10 mmol/l).

the study duration for each patient will be 27 weeks.

Eligibility criteria:
inclusion criteria : * 18 to 65 years old. * type 2 diabetes patients insufficient controlled by 1-3 oral anti-hyperglycemic drugs (oads) with stable dose at least 3 months: * if on 1 oad, provided with the following doses (including but not limited to): * α-glucosidase inhibitor: 100mg, three times a day (tid); * metformin: 1.5-2.0 g/day; * sulphonylureas: sub-maximum (half dose above) to maximum tolerated dose; * thiazolidinediones: eg. pioglitazone, 30-40 mg/day. * besides the medications listed above, if on 1 oad, others should be maximum tolerated dose allowed in package insert. * if on 2-3 oads, any range of dose is acceptable. * hba1c \>7%, and ≤10.5%. * fpg \>7 mmol/l. * body mass index (bmi) ≥20 kg/m\^2, and ≤40 kg/m\^2. * diabetes duration ≥1 year. * physician decides to and the patient is willing to start basal insulin (bi) treatment. * willing to join the study and sign the informed consent. exclusion criteria: * type 1 diabetes patients. * patients with acute diabetic complications (including unexplained severe hypoglycemia in the last 6 months). * previous treatment with insulin for more than 1 month cumulatively in last 1 year, or treatment with insulin in the last 3 months before the screening. * known hypoglycemia unawareness or recurrent hypoglycemia. * hypersensitivity to study drug or its excipients. * any clinically significant acute major organ or systemic disease, or any other situation judged by the investigator, that is difficult for the 24 weeks follow-up. * pregnancy or breastfeeding women. * have any mental disorders, lack self-control or not able to express accurately. * involved in another clinical trial simultaneously or within a 1 month before start of trial. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
study on the antiaging effect of chinese herb drink

Conditions: Gynecological Disorders

Summary: the purpose of the current study was to check the physiological improvement of swt on liver and skin and also the antioxidation in healthy adults.

background: si-wu-tang (swt) is a well-known traditional chinese medicine (tcm) and widely used for treating various gynecological disorders. the purpose of the current study was to check the physiological improvement of swt on liver and skin and also the antioxidation in healthy adults. methods: sixty healthy voluntary subjects were recruited and assigned into two groups, who drank 125 ml of placebo (n=30) or swt (n=30) for 6 continuous days per month during the following 6 months and vice versa with one month of washout period in between. during the initial, 3rd, 6th, 10th, and 13th months anthropometric measurements were performed as well as fasting blood samples were drawn for various biochemical assays. abdominal ultrasonic and skin examination were performed at the initial, 6th and 13th months.

Eligibility criteria:
inclusion criteria: * healthy adults exclusion criteria: * exclusion criteria were history of smoking, alcoholism * pregnant or lactating women, * chronic diseases, hepatic or renal dysfunction.

Keywords: si wu tang antioxidation anthropometric measurements liver skin
home non-invasive ventilation for chronic obstructive pulmonary disease patients

Conditions: Chronic Obstructive Pulmonary Disease; Hypercapnic Respiratory Failure

Summary: chronic obstructive pulmonary disease (copd) patients with chronic hypercapnic respiratory failure are more likely to develop exacerbations. non-invasive ventilation has been proposed to treat acute respiratory failure but little information is available about the benefits of home non-invasive ventilation in copd patients with chronic hypercapnic respiratory failure surviving an acute hypercapnic respiratory failure. the purpose of this study is to determine whether home non-invasive ventilation can reduce recurrent acute hypercapnic respiratory failure in copd patients who survived an episode of acute hypoxemic respiratory failure (ahrf) treated by non-invasive ventilation (niv).


Eligibility criteria:
inclusion criteria: * age \> 18 years old * copd patients who survived after an episode of acute hypercapnic respiratory failure * patients weaned from ventilation (non invasive ventilation or mechanical ventilation) for acute episode since at least seven days with stable arterial blood gas since at least two days: paco2 \> 55 mmhg and ph \> 7.35 exclusion criteria: * age \> 85 years old * non- copd causes of respiratory failure * obstructive sleep apnea excluded by polysomnography * adverse psychosocial status * serious co-morbidity
hands on - a hand care guide in systemic sclerosis

Conditions: Scleroderma

Summary: hands are commonly affected in systemic sclerosis (ss). the objective of this research is to apply a home based hand care guide in patients with ss and to evaluate its response regarding hand pain, function, strength and mobility.

introduction: hands are commonly affected in systemic sclerosis (ss). skin thickening, raynaud phenomenon, digital ulcers and cutaneous calcinosis may result in pain, disability and claw deformity. strategies to improve hand function are recommended since its diagnosis and throughout the treatment. unfortunately hand care assistance is not often available. the objective of this study was to developed a brief guide about hand care and home-based exercises to be applied in our outpatient clinic. methods: a brief program , with instructions about the disease and home-based exercises will be applied in a group patients with systemic sclerosis (ss) during the period of 12 weeks. hand function (cochin hand and functional scale), disability (haq-scleroderma), quality of life (sf-36 hand pain (visual analogue scale), grip and pinch strength, hand mobility (delta finger) will be assessed in the first appointment and after twelve weeks.

Eligibility criteria:
inclusion criteria: * diagnosis of systemic scleroderma according to the american college of rheumatology (criteria committee, arthritis rheum. 2013). * involvement of hands with skin thickening. * interest in participating in the investigation * ability to read and to answer the the proposed questionnaires exclusion criteria: * upper limb commitment due other reasons other than systemic sclerosis. * presence of digital ulcers, hand deformities or conditins that impede the realization of the proposed exercises * clinical manifestations that impede the performance of the proposed exercises
neoadjuvant chemotherapy in upper tract urothelial carcinoma : a retrospective multicentric study.

Conditions: Upper Excretory Tract Tumors

Summary: upper tract urothelial carcinoma incidence is about 1 /100000/year. these tumors are mostly diagnosed at an invasive stage and the standard treatment is a total nephroureterectomy. in this population, indication of perioperative chemotherapy is still discussed. the benefit of platinum-based adjuvant chemotherapy was recently confirmed by the prospective trial pout for pt2-t4 n0-3 m0 tumors with an improvement in recurrence-free survival of 51% in the chemotherapy arm. however, in this situation, use of adjuvant cisplatin-based chemotherapy may be limited by the deterioration of renal function due to renal surgery. there are currently no recommendations on the place of neoadjuvant chemotherapy (nac) with controversial results. moreover, the impact on renal function of the nac-nut treatment sequence has so far been little studied. the aim of this study is to improve scientific knowledge about neoadjuvant chemotherapy in upper tract urothelial carcinoma eligible to a curative surgery. the investigators will evaluate the benefit of nac on pathological response, overall survival and progression-free survival in a large multicentric cohort. in addition, the investigators will assess the impact of nac on renal function at a distance from curative surgery will allow the evaluation of its specific toxicity.


Eligibility criteria:
inclusion criteria: 1. patients over 18 years of age 2. male or female 3. upper excretory tract tumors 4. localized or locally advanced stage (n0 to n1) 5. eligible for curative surgery 6. have received neoadjuvant or primary chemotherapy 7. neoadjuvant chemotherapy treatment received between 2010 and 2020. exclusion criteria: 1. patient's opposition to the research 2. utuc not eligible for curative surgery 3. locally advanced utuc ≥ n2 and/or metastatic.
comparison of the efficacy of two rituximab treatment regimens in patients with lupus nephropathy

Conditions: Lupus Nephritis

Summary: comparison of the efficacy of two rituximab treatment regimens in patients with lupus nephropathy resistant to conventional treatments

randomized, open, controlled, multicenter, clinical trial in patients with lupus nephritis previously treated with cyclophosphamide and mycophenolate. these patient can not have received rituximab in the previous year. the number of patients estimated to reach statistical significance is 18 in each arm, a total sample size of 32 patients is needed. the hypothesis is that the alternative procedure (a second cycle of rituximab)will reduce the relapse rate of lupus nephritis and the consequent deterioration of renal function. besides it will reduce health care expenses(hospitalization, medication, hemodialysis and renal transplantation).

Eligibility criteria:
inclusion criteria: * both men and women between 18 and 70 years. * patient with active lupus nephritis, previously treated with cyclophosphamide and mycophenolate (sodium or mofetil), who have not received rituximab in the previous year. * women in childbearing age must have a pregnancy test in serum or urine negative and should use a contraceptive method suitable since at least 14 days prior to their inclusion in the study and up to 6 months after the last dose of the medication of the test. * informed consent form signed. exclusion criteria: * patients treated with rituximab in the previous years * active/sepsis serious infections * renal biopsy showing interstitial fibrosis and/or glomerular over 75%. * known neoplasia * heart failure with iii/iv functional class * pregnancy * nursing * known anaphylaxis to the product * history of hepatitis c * history of tuberculosis * cardiovascular disease or uncontrolled hypertension * chronic hepatitis b * serious cytopenia (granulocytes \< 500/mm3, further \< 10000/mm3) * immunodeficiency (cvi, immunoglobulins deficiency) * infection with hiv

Keywords: lupus nephritis remission immunosuppressive treatment
effect of heliox on rsv bronchiolitis

Conditions: RSV Infection; Acute Bronchiolitis

Summary: helium is an inert gas with a density almost one-seventh of that of air. based on its properties breathing a mixture of helium and oxygen (heliox) will lead to a reduction in resistance through narrowed airways and consequently decreases the work of breathing. participating infants with rsv acute bronchiolitis will be supplied with heliox (ration of 21 oxygen and 79 helium) delivered through a flow nasal cannula to evaluate heliox effect in improving their oxygenation. heliox will act as an additive therapy to improve oxygenation in patients with lower respiratory tract infection caused by respiratory syncytial virus (rsv) and will decrease the need for more complicated therapies.


Eligibility criteria:
inclusion criteria: * age fro 1 month till 2 years * rsv acute bronchiolitis without any supplemental oxygen. exclusion criteria: * oxygen supplement or mechanical ventilation requirement * congenital anomalies of the heart * chronic lung disease including bronchopulmonary dysplasia * failure to obtain an informed consent.

Keywords: heliox
an observational study of lung cancer related symptoms and disease control rate in patients with non-small cell lung cancer receiving first-line platinum-based chemotherapy with or without avastin (bevacizumab)

Conditions: Non-Squamous Non-Small Cell Lung Cancer

Summary: this prospective observational study will evaluate the evolution of lung cancer related symptoms and their correlation with the disease control rate (complete response, partial response and stable disease) in patients with non-small cell lung cancer initiating first-line treatment with standard platinum-based chemotherapy with or without avastin (bevacizumab). data will be collected from each patient at baseline and after 4-6 cycles of chemotherapy.


Eligibility criteria:
inclusion criteria: * adult patients, \>/= 18 years of age * histologically or cytologically confirmed non-small cell lung cancer * initiating first-line treatment with standard platinum-based chemotherapy, with or without bevacizumab exclusion criteria: * contraindications to the use of platinum-based chemotherapy
pilot study of cabazitaxel and paclitaxel in her2 negative breast cancer

Conditions: HER2 Negative Metastatic Breast Cancer

Summary: 90 patients with her2 negative breast cancer will be randomised to receive 18 weeks of chemotherapy treatment, either 6 cycles of 3 weekly cabazitaxel or 6 cycles of weekly paclitaxel to determine the difference in progression free survival between the 2 groups. if results at that stage suggest a potential benefit then the trial will be developed further to accrue 70 more patients.

this is a prospective multicentre, randomised, open label, study comparing the efficacy and the safety of six 3-weekly cycles cabazitaxel versus 18 x weekly paclitaxel given as first line chemotherapy treatment in patients with her2-normal metastatic breast cancer. randomisation will be conducted by a 1:1 ratio.

Eligibility criteria:
inclusion criteria: * written informed consent * metastatic breast cancer fit to receive cytotoxic chemotherapy for metastatic disease * measurable disease as per recist 1.1 * her2 negative defined as ich 0+, 1+ or 2+ and fish/sish/cish(ration\<2.0) in the case of ihc 2+ * ecog performance status 0 or 1 * er+ve or er-ve * female age ≥18 years * anticipated life expectancy \> 6 months * haemoglobin \>10.0g/dl * absolute neutrophil count\>1.5 x 10\^9/l * platelet count\>100 x 10\^9/l * alt/sgpt\<1.5 x uln * serum creatinine \<1.5 x uln * negative pregnancy test for all women of child bearing potential exclusion criteria: * grade ≥2 oral mucositis or peripheral or sensory neuropathy * history of other malignancy * history of severe hypersensitivity ≥grade 3 to polysorbate 80- containing drugs and taxanes * clinically significant cardiovascular disease * any acute or chronic medical condition * acute infection requiring systemic antibiotics or antifungal medication * sex hormones * administration of any live vaccine within 8 weeks * concurrent or planned treatment with strong inhibitors or strong inducers of cytochrome p450 3a4/5 * participation in another clinical trial with an investigational drug within 30 days of randomisation * pregnant or breast feeding women * contraindications to the use of corticosteroid treatment * her2 positive breast cancer * previous paclitaxel chemotherapy in the adjuvant setting * previous cytotoxic chemotherapy for metastatic disease * palliative radiotherapy for metastatic disease within 4 weeks of randomisation * symptomatic brain metastases confirmed with ct/mri brain * history of other malignancy * grade 2

Keywords: breast cancer her2 negative cabazitaxel paclitaxel chemotherapy
communication skills vs. mindfulness for ipv

Conditions: Domestic Violence; Domestic Abuse; Family Conflict; Aggression

Summary: this tests the immediate impact of two brief interventions on couples reporting intimate partner violence using the proximal change experimental design. couples will be randomly assigned to a mindfulness conditions, a communication exercise or a placebo condition. outcome measures include observed and experimentally assessed aggression.

this pilot study is designed to test the effects of two brief interventions on communication and emotional expression between intimate partners who have experienced recent domestic violence. in addition, it will provide some basic laboratory findings on differences in distress tolerance between perpetrators and victims of domestic abuse. specifically, using the proximal change experimental design, couples will engaged in a 7.5 minute conflict discussion while being videotaped and having their autonomic responding monitored. then they will be randomly assigned to one of three conditions: a communication skills training exercise, a mindfulness condition, or a placebo control. next, ,couples will engaged in second 7.5 minute conflict discussion. it is hypothesized that those in both the communication skills training and mindfulness condition will display more positive and less aggressive behavior in their second conflict discussion as compared to their first. it is also expected that they will administer less aggression (as measured by delivery of a loud noise) to their partner after both of the active interventions. in addition, multiple measures of distress tolerance will be administered to both partners. it is expected that couples with a characterologically violent perpetrator, he or she will evidence decreased distress tolerance and the victimized partner will evidence increased distress tolerance

Eligibility criteria:
inclusion criteria: adult co-habituating couples reporting some violence in the past year (score \> 0 on cts2 physical abuse subscale) exclusion criteria: homosexual couples children under 18 non-english speakers

Keywords: intimate partner violence aggression batterers intervention mindfulness communication skills couples
plan for microwave thermal field

Conditions: Hepatocellular Carcinoma; Ablation

Summary: develop an intelligent system based on contrast-enhanced ultrasound and clinical information to help doctors automatically obtain ablation parameters (ablation needle number, ablation needle type, ablation time,ablation power) when preparing to use microwave ablation to treat hepatocellular carcinoma


Eligibility criteria:
inclusion criteria: 1. biopsy or clinical diagnosis of hcc 2. complete clinical information and preoperative ceus 3. curative treatment exclusion criteria: 1. palliative care 2. intolerance to ablation 3. severe coagulation disorder

Keywords: hepatocellular carcinoma microwave ablation
comparison between double tract anastomosis and esophagogastrostomy after radical proximal gastrectomy

Conditions: Gastric Cancer; GastroEsophageal Cancer

Summary: the patients with upper gastric cancer (ct1n0m0) or gastroesophageal adenocarcinoma (diameter less than 4 cm) will be enrolled into this study. each of these patients will undergo radical proximal gastrectomy and be randomly allocated into one of the two groups, double tract anastomosis group or esophagogastrostomy group. the following data will be collected to compare the difference between the two reconstruction methods: the rate of reflux esophagitis, postoperative quality of life, economic expenditure, the safety of operation, postoperative recovery, postoperative nutrition status and oncological effect. through the comprehensive analysis, the result of this study will elucidate the best of the reconstruction method after proximal gastrectomy.


Eligibility criteria:
inclusion criteria: 1. patients diagnosed as gastric or esophagogastric adenocarcinoma 2. age ranges from 18 to 80 3. karnofsky assessment no less than 70 4. completion of abdominal ct scan and ultrasound endoscopy 5. upper gastric cancer (ct1n0m0) or esophagogastric adenocarcinoma (diameter no more than 4 cm) 6. radical proximal gastrectomy 7. normal blood routine examination and biochemical test exclusion criteria: 1. patients need to undergo total gastrectomy or distal gastrectomy 2. female patients with pregnancy 3. not suitable for operation 4. patients have already joined other clinical trials

Keywords: double tract esophagogastrostomy gastric cancer gastroesophageal cancer
pulmonary alveolar proteinosis gm-csf inhalation efficacy trial in japan

Conditions: Pulmonary Alveolar Proteinosis, Autoimmune

Summary: objective: determine the safety and efficacy of gm-csf inhalation in patients with apap. study design: multi-center, randomized, double-blind, placebo- controlled, safety/efficacy study.


Eligibility criteria:
inclusion criteria: 1. age over 16 years and below 80 years (as of the date of registration). 2. can provide signed informed consent. 3. willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures specified in the protocol (including short-term hospital admission). 4. autoimmune pulmonary alveolar proteinosis diagnosed by both hr-ct and biopsy and/or bal as well as gm-csf antibodies in serum positive. 5. pao2 \< 70 mmhg after 5 minutes spine position at room air, or pao2 \< 75 mmhg after 5 minutes spine position at room air and with symptom(s) including cough, sputum and exertional dyspnea exclusion criteria: 1. diagnosed as secondary or hereditary pulmonary alveolar proteinosis 2. wbc of 12,000/mm3 or more 3. fever of 38 degree celsius or more 4. severe edema 5. history of malignant disease within recent 5 years (not applied to the treated cases of uterine carcinoma in situ and local basal cell carcinoma) 6. complication of cardiovascular diseases including congestive heart failure, angina pectoris, hemorrhagic tendency, etc with severe condition. 7. complication of respiratory diseases such as pulmonary infectious disease(incl. pulmonary tuberculosis), bronchial asthma, lung fibrosis ,interstitial pneumonitis, or bronchiectasis, in which the evaluations of safety and efficacy of gm-csf therapy are considered as difficult. 8. history or complication of infectious diseases which require systemic administration of antibiotics, antifungal or antiviral agents within recent 2 weeks. 9. treatment with other cytokines 10. pregnant or possibly pregnant women, lactating women, and women who desire to become pregnant during the study period 11. patients who have been treated with whole-lung lavage, repeated segmental-lung lavage, or rituximab within 6 months before the start of the study (this criterion does not apply to patients for whom 6 months or more have elapsed after their last lavage or rituximab) 12. severe liver dysfunction (ast \> 100 iu/l and/or alt \> 100 iu/l and/or t-bil \>3.0mg/dl) 13. severe renal dysfunction (ccr \< 30 ml/min, calculated by cockcroft-gault (cg) formula) 14. previous experience of severe and unexplained side-effects during aerosol delivery of any kind of medicinal product 15. treatment with oral or intravenous administration or inhalation of corticosteroids. 16. treatment with other inhaled drugs. 17. previously treated with gm-csf before the start of the study. 18. demonstrate hypersensitivity to gm-csf agent. 19. other patients judged to be inappropriate for the study by the attending physician (e.g., patients who are unlikely to complete treatment or are uncooperative).